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Natus Medical Incorporated recalls External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Recalled January 10, 2024 · FDA recall Z-0634-2024 · Natus Medical Incorporated
Hazard
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. · FDA Class II
Units
2,686 units
Sold at
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.
Description
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Product
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Manufacturer(s)
Natus Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →